Targeting HIV Settings Through PEPFAR. Bill Coggin, OGAC PEPFAR Laboratory Technical Working Group

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1 Targeting HIV Settings Through PEPFAR Bill Coggin, OGAC PEPFAR Laboratory Technical Working Group

2 PEPFAR Laboratory Program is a Critical part of Health Systems Strengthening Mission: To support countries to strengthen sustainable, integrated laboratory systems to provide quality diagnostic services for effective implementation of prevention, surveillance and treatment programs across diseases (HIV, TB, Malaria, OIs)

3 The Maputo Declaration on Strengthening of Laboratory Systems Call on national governments to support laboratory systems as a priority by developing a national laboratory policy within the national health development plan that will guide the implementation of a national strategic laboratory plan. Governments should establish a department of laboratory systems within the Ministry of Health. Call on national governments with support of their donors and partners in resource-limited settings to develop national strategic laboratory plans that integrate laboratory support for the major diseases of public health importance including HIV, tuberculosis, and malaria.

4 Laboratory Systems Framework For Strengthening Laboratory Systems and Services Serology Molecular Testing Hematology Chemistry CD4 Culture Microscopy Strengthening Laboratory Health Systems Effective, Functional & Sustainable Care and Treatment, PMTCT, VCT, Early Infant Diagnosis, Tuberculosis, Malaria, STDs, ---etc Policies, Plans & Financial Systems Training & Human Resource Systems Quality Management Systems Biosafety Systems Equipment Procurement, Validation & Maintenance Systems Supply Chain Management Systems Laboratory Information & Data Management Systems Specimen Transport & Sample Referral Systems Laboratory Services

5 Laboratory Systems Training Center Laboratory Strategic Plans/Policies Quality Management Systems and Accreditation

6 Laboratory Services Support for: HIV Rapid Testing/Incident Testing Clinical Monitoring Early Infants Diagnosis HIV Drug Resistance TB/OI Diagnosis & Treatment Monitoring

7 Number of PEPFAR-Supported Laboratories in Selected Countries as of September 2008 (N= 1,917)

8 TB, HIV, Malaria - Integrated Training Center, Zaria, Nigeria

9 African Centre for Integrated Laboratory Training at NHLS/NICD Johannesburg Vision A healthier Africa through quality laboratory practices that support efforts to combat major infectious diseases Mission To provide integrated hand-on training courses to expand laboratory capacity in Africa for diagnosis and monitoring of major infectious diseases including HIV, TB and malaria

10 Resource allocation in PEPFAR TB/HIV a stated priority in PEPFAR II yet competing among other HIV prevention, care, and treatment priorities Country Operational Plan (COP) Process HQ determines overall country allocations Technical working group provides technical guidance Country-level decentralized planning Country-level processes vary Reflect host country governments strategies and priorities (eg National Lab Strategic Plans) Need for continued advocacy and CSO support

11 2011 TB/HIV technical considerations, labs Reflect WHO normative guidelines Extracts ref laboratories: Strengthen national reference laboratories to provide quality assurance, mycobacterial culture, and TB drug-susceptibility testing, as well as newer diagnostic methods for rapid identification of TB and MDR-TB Support development and implementation of new diagnostic algorithms to incorporate newer diagnostic methods for TB and MDR- TB, and procedures to diagnose smear negative, extrapulmonary, and pediatric TB as they become available. Focus on improving quality as well as access to TB laboratory services for PLHIV, via solutions such as strengthening on-site TB labs at ART clinics or supporting specimen transport and lab information management systems.

12 Procurement Options in PEPFAR Partner contracts and agreements (eg MoH CoAgs) Local procurements (eg via US Embassy, agencies) USG Headquarters mechanisms Supply Chain Management System (SCMS) TWG advises on procurement options Advice on large-scale purchasing of laboratory supplies and equipment Provide guidelines on selection and budgeting for purchases of laboratory equipment, supplies, and reagents for procurement through SCMS. Support a unified approach with manufacturers, vendors, and partners to procurement and distribution of laboratory commodities

13 SCMS Lab Procurement By Value in FY 2010: Equipment: $38,317,755 (43%) Test kits: $20,602,428 (32%) All other products represent about 25% of lab procurement dollars Cost savings of pooled procurement of lab equipment (as with ARVs) have yet to be realized. 13

14 Conclusion PEPFAR is committed to integrated lab systems that yield measurable benefit across disease programs and further systems strengthening imperatives PEPFAR-supported HIV care & treatment infrastructure offers a natural platform to demonstrate implementation of new diagnostics More rapid and accurate diagnostic is an important pathway to Three Is, a priority in HIV care PEPFAR programming takes lead from MOH policies and WHO normative guidance PEPFAR welcomes partnerships to further roll-out of new diagnostics for TB that reduce the burden of TB in HIVaffected communities

15 Acknowledgements Heather Alexander, CDC John Nkengasong, CDC Joel Kuritsky, USAID PEPFAR Laboratory Technical Working Group